Effects of Moderate Altitude Training on Metabolic Parameters in Voluntary Study Participants With Metabolic Syndrome
The metabolic syndrome is a cluster of metabolic disorders (obesity, hyperglycemia, dyslipidemia and hypertension) and it is a risk factor for the development of type 2 diabetes and atherosclerotic cardiovascular disease. There are several definitions for the metabolic syndrome. The AHA/NHLBI (American Heart association/National Heart Lung Blood Institution)and IDF (International Diabetes Federation)2009 criteria are frequently used to comparing data from studies. Prevention or reduction of obesity and lifestyle modification with physical activity is the main therapeutic goal in patients with metabolic syndrome. Recent studies have shown that exercise in moderate altitude or in moderate hypoxia improved glycemic parameters. The influence of training in moderate altitude on circulating metabolites and hormones in terms of substrate utilization is unclear. The adiponectin seems to play an important role in the homeostasis of adipose tissue and in the pathogenesis of the metabolic syndrome and physical activity seems to have a positive effect on adiponectin concentrations. In this study with randomized controlled pretest-posttest-design we want to investigate the effects of physical activity in moderate hypoxia on biomarkers of metabolic syndrome.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||Randomized Controlled Trial to Analyze the Effects of Moderate Altitude Training on Metabolic Parameters in Voluntary Study Participants With Metabolic Syndrome.|
- exercise test [ Time Frame: examination after 2 weeks of exercise ] [ Designated as safety issue: Yes ]
- BMI, BIA, metabolic and cardiorespiratory parameters [ Time Frame: examination on baseline and after the 2 weeks ] [ Designated as safety issue: Yes ]
- blood pressure, heart rate [ Time Frame: at baseline and after 2 weeks of exercise ] [ Designated as safety issue: Yes ]
- blood pressure, heart rate [ Time Frame: at baseline and after 2 weeks of exercise ] [ Designated as safety issue: No ]
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|lifstyle modification||Other: training program in low and moderate altitude|
Participate can subjects aged 40-70 years with metabolic syndrome according to the definition of AHA/NHLBI and IDF 2009 after declaring orally and written consent and if they authorize to process personal and sanitary data. The study involve 80 subjects with metabolic syndrome. They will be recruited by general practitioner, elect from the principal investigator and invited to participate in the trial. The 80 participants will be randomized in two groups.
Group A, moderate altitude group, 1900 m, 40 participants Group B, low altitude group, 400m, 40 participants Group A will spend 2 weeks at an altitude of 1900m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).
Group B will spend spend 2 weeks at an altitude of 400m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).
Nutrition does not follow any specific diet plan, both groups receive an equivalent balanced feeding.
Clinical examinations at the beginning and at the end of the study laboratory tests well be documented and compared(fasting plasma glucose, triglycerides, HDL-C, LDL-C, insulin, C-peptid, free fatty acids, adiponectin, leptin, HbA1c, Metabolon cluster, c reactive protein, vit D3). Also BMI, BIA bioimpedance analysis, blood pressure, heart rate, egg, Physical status, exercise test.
|Contact: Ivana Gutwengeremail@example.com|
|Bressanone, Bolzano, Italy, 39042|
|Contact: Ivana Gutwenger 00390472813838 firstname.lastname@example.org|
|Contact: Georg Hofer 003903355630697|
|Principal Investigator: Ivana Gutwenger|
|Principal Investigator:||Ivana Gutwenger||Pure Mountain Solda|